EP0810001B1 - Device for treating male and female bladder emptying disorders - Google Patents

Description

The invention relates to a device for the treatment of urinary bladder emptying disorders of the man and the woman according to the preamble of claim 1.

Urinary incontinence is the involuntary loss of urine from the urinary bladder and urethra. The causes are either direct damage to the occlusive device (sphincter) of the bladder, usually as a result of a prostate operation or by infiltration of a prostate carcinoma in men or a sphincter injury by birth in women. Other causes of urinary incontinence include nerve damage as a result of metabolic diseases, e.g. Diabetes mellitus or as a result of trauma to the nerves supplying the bladder and its occlusive mechanism, such as stroke, pelvic tumor surgery or spinal cord injury.

When incontinence as a result of nerve damage usually the closure mechanism of the bladder can not be opened sufficiently, so that the urine loss (incontinence) occurs only after maximum filling of the bladder into the bladder not quite emptying amount and uncontrollable. The consequences are in addition to the wetting an overstretching the urinary bladder and in many cases the backflow of urine into both kidneys with subsequent kidney damage. Of the various forms of incontinence are usually affected people of higher age.

For the treatment and remedy of urinary incontinence, various methods are already known, depending on the cause of the same and depending on gender, but in severe cases are usually not effective enough or require surgery with or without an implant and are not always free of disadvantages.

In incontinence by partial or complete loss of function of the occlusive device of the bladder, especially in men, the application of an surgically implantable artificial bladder sphincter after "Scott" known (AMS 800 of the company American Medical Systems). The implant is very expensive and should only be implanted by experienced doctors. Serious infections of the tissue surrounding the implant or necrosis thereof by pressure with necessary removal of the implant were repeatedly observed. In women, this form of incontinence is often a successful physical therapy or a low-burden surgery without an implant.

Another known device for eliminating the incontinence of the man consists of a so-called penile clamp or a Penoring, which is exerted by pressure from the outside of the penis or the urethra more or less traumatizing pressure. In addition, there is a risk of slipping in the underwear with soaking.

Furthermore, for both sexes worn outside the body urine collection systems with urine bags (urinals) or absorbent aids (disposable diapers) are known, which serve to collect the urine and skin irritation through the urine, odor and thus social isolation result.

In addition, a device for incontinence of the woman is known, wherein the bladder is emptied via a short protruding from the urethra catheter by manual actuation of a present in the vaginal vestibule valve ( EP 0 407 218 A1 ). The valve located in the vaginal vestibule should lead to a colonization of the device by vaginal vestibular bacteria.

Recently, a device for female incontinence under the name "Reliance ™" is on the market ( US-A-5090424 ), which consists of an inflatable urethra insert that has to be removed several times a day before each bladder emptying similar to a tampon and then replaced with a new device, which is very expensive.

Also, an incontinence catheter having an elongated tube member insertable through the urethra into the bladder lumen of a human is known ( U.S.-A-3,331,371 ) which is held in the bladder lumen by an inflatable holding balloon surrounding the tube member and which has a valve at its end portion inserted into the bladder lumen. This valve can be realized in different ways.

In one embodiment, at its end portion inserted in the bladder lumen, the tube part has a fluid inlet hole closed by a movable rubber ball in the unactuated valve state, which is connected to a passage extending along the relevant tube part. The rubber ball is connected to a rope assembly, one end of which must be led out of the urethra so that the rubber ball can be moved out of its sealing system at the fluid inlet hole by pulling on this Seilanordnungsende so that then urine can be removed from the bladder lumen through the tube part. As a result, in this realization of the known incontinence catheter, however, corresponding problems arise due to a colonization rising from the outside into the bladder with bacteria, as has been mentioned above in connection with another known device.

In another embodiment, at its end portion inserted in the bladder lumen, the tube part has a fluid inlet hole open in the unactuated valve state, which is connected to a passage extending along the tube part in question and which can be closed by a sealing balloon inflatable by means of a gas or a fluid. However, how and by what means the inflation of the respective sealing balloon takes place is not specified in the relevant context.

The preamble of claim 1 relates to this embodiment.

Finally, devices for incontinence of the man are known with which, in principle, a number of the above enumerated disadvantages can be avoided ( US-A-4946449 , DE-OS 40 14 369 = US-A-4932938 . EP-A-0 265 207 . EP 0 543 309 B1 ). These known devices essentially consist of a catheter which can be introduced into the male urethra and has at its proximal end section a balloon which can be filled with a fluid (for example water) and thus can be expanded. This balloon seals the urinary bladder from entering the urethra and secures the catheter from accidentally slipping out. Disposed distally of the balloon is a fluid-fillable second balloon, which in the inserted state of the catheter is located outside the bladder sphincter in the urethra and thus prevents unwanted displacement of the catheter into the bladder interior. The length of the catheter is sized so that its distal end is fully seated in the inserted state in the penis, and in the distal end portion is disposed a valve which is palpable from outside through the wall of the urethra in the area of the penis. The valve is for example a beak, lip, ball or sliding valve, the normally closed state can be transferred by pressure between two fingers in the open state, so that the voiding can take place. These known valves located at the distal end portion of the catheter have several serious disadvantages. The lumen cross-section of a catheter is at most 5-6 mm, which is why the production of miniaturized on these dimensions lip or beak valves difficult or inexpensive not possible at all. On the closed valve loads in the opening direction by the internal pressure of the bubbles, a liquid pressure of up to 100 cm of water, so that the risk of turning the valve to the outside and thus a loss of function is preprogrammed. The silicone material used almost exclusively for long-acting catheters has only a low rubber-elastic restoring force, so that lip and beak valves made of this material require a metal-elastic spring device in order to achieve a return of the opened valve to a sealing, closed position. To realize this spring device in the mentioned small dimensions is also technically very complicated. Metallic devices in the catheter wall also result in hardening thereof and increase the risk of pressure related damage to the delicate urethral mucosa. All of the aforementioned valves attached to the distal end of the catheter lead to a significant loss of catheter lumens. This is especially true for ball or slide valves, so that in these open state no sufficient flow of urine is guaranteed. Non-deformable valve elements, such as balls, also tend to increased encrustation by the substances dissolved in the urine.

The invention is therefore based on the object, a device for the treatment and remedy especially the male urinary incontinence of the type mentioned in such a way that the catheter valve is easy to produce, by a sufficient elastic restoring force closes securely, even at high bladder pressures automatically opens, the catheter lumen is largely in its entire cross section for arbitrary drainage of urine from the bladder available and the insertion of the device into the urethra and their removal is easy. In addition, the device should be based on the same basic principle, but after adaptation to the different anatomical conditions of the woman, also to treat and remedy the urinary incontinence of the woman.

According to the invention this object is achieved with a device of the type mentioned by the embodiment of the device according to the characterizing part of claim 1.

The device according to the invention is an incontinence catheter which can be lowered completely into the urethra and has two sealing balloons, whereby the valve occluding the catheter is located at the proximal end of the catheter projecting into the bladder. Valve orifice is opened by finger pressure on an additional balloon, palpable at the distal end of the catheter and through the urethral wall, filled with fluid (eg, water), which is connected through a channel in the catheter wall to the valve present at the proximal end of the catheter. The design features of this triggered by a hydraulic mechanism valve do not correspond to a previously known catheter valve and do not lead to a reduction of the drainage lumen of the catheter when the valve is open, so that a sufficient urinary jet is ensured. The miniaturization of a catheter valve on the size of the inner cross-section of the catheter and the associated difficulties in industrial production omitted. The valve is automatically closed by a simple spring-elastic mechanism after the finger pressure on the distal catheter balloon has ended. At high internal bladder pressure, the tightness of the valve closure is additionally increased.

The inventive attachment of the valve at the proximal end of the catheter allows the use of the device in a modified manner as a completely retractable incontinence catheter without connection to the body surface, whereby an ascending from the vaginal vestibule, occurring regularly in catheters or outer catheter valves inflammation of the bladder is avoidable ,

The introduction, positioning and filling of the catheter balloons with a fluid (e.g., water) is accomplished through a disposable, special, sterile introducer rod.

Removal of the device from the urethra is accomplished by another disposable, specially designed sterile rod which separates the distal portion of the catheter, thereby draining the fluid (e.g., water) from the balloons. In principle, the removal of the device from the urethra can also take place under the view through a cystoscope with the help of a known foreign body forceps.

Both the male and female incontinence catheters are thus relatively simple in construction, eliminating the technically barely practicable miniaturization of a valve accommodated in the distal catheter lumen, so that the incontinence catheters can be inexpensively manufactured as disposables. Production requires no hitherto unknown technical procedures. The materials in question are physiologically compatible plastics based on silicone or latex, optionally with a known hydrophilic silver coating for additional avoidance of germ colonization and with good compatibility with the mucous membrane, as well as monofilament surgical thread material. Leaving the catheter in the lower urinary tract for several weeks to months is therefore possible.

• FIG. 1 eine schematische Darstellung des männlichen Inkontinenzkatheters mit teilweiser Abbildung des Einführungsstabes,
• FIG. 2 eine schematische Darstellung des weiblichen Inkontinenzkatheters mit teilweiser Abbildung des Einführungsstabes,
• FIG. 3 eine schematische Darstellung des baugleichen männlichen und weiblichen proximalen Katheterendes bei geschlossenem Ventil in seitlicher Ansicht,
• FIG. 4 eine schematische Darstellung des baugleichen männlichen und weiblichen proximalen Katheterendes bei geschlossenem Ventil, mit Sicht auf die der Ventilöffnung gegenüberliegende Seite,
• FIG. 5 eine schematische Darstellung des baugleichen männlichen und weiblichen proximalen Katheterendes bei geöffnetem Ventil in seitlicher Ansicht,
• FIG. 6 eine schematische Darstellung des erfindungsgemäßen männlichen Inkontinenzkatheters im eingesetzten Zustand in der männlichen Harnröhre, wobei das in die Harnblase einragende Katheterventil geschlossen ist,
• FIG. 7 eine schematische Darstellung des erfindungsgemäßen weiblichen Inkontinenzkatheters in der weiblichen Harnröhre bei geöffnetem Ventil,
• FIG. 8 eine schematische Darstellung des männlichen Inkontinenzkatheters mit aufgesetztem Einführungsstab in der männlichen Harnröhre während der Füllungsphase der Ballons,
• FIG. 9 eine schematische Darstellung des distalen Teiles des männlichen Inkontinenzkatheters in der männlichen Harnröhre im Moment der Ablösung des Einführungsstabes,
• FIG. 10 eine schematische Darstellung des distalen Teiles des männlichen Inkontinenzkatheters in der männlichen Harnröhre während des Einführens der speziellen, stabförmigen Entfernungsvorrichtung,
• FIG. 11 eine schematische Darstellung des distalen Teiles des männlichen Inkontinenzkatheters in der männlichen Harnröhre zu Beginn der Extraktion durch die Entfernungsvorrichtung, und
• FIG. 12 eine schematische Darstellung des distalen Teiles des weiblichen Inkontinenzkatheters in der weiblichen Harnröhre zu Beginn der Extraktion durch die Entfernungsvorrichtung.

Depending on an embodiment of the male and female urethra are explained in more detail with reference to the accompanying drawings. In the drawings show:

• FIG. 1 a schematic representation of the male incontinence catheter with partial imaging of the insertion rod,
• FIG. 2 a schematic representation of the female incontinence catheter with partial imaging of the insertion rod,
• FIG. 3 a schematic representation of the identical male and female proximal catheter end with the valve closed in a side view,
• FIG. 4 a schematic representation of the identical male and female proximal catheter end with the valve closed, with a view of the valve opening opposite side,
• FIG. 5 a schematic representation of the identical male and female proximal catheter end with the valve open in a side view,
• FIG. 6 a schematic representation of the male incontinence catheter according to the invention in the inserted state in the male urethra, wherein the protruding into the bladder catheter valve is closed,
• FIG. 7 a schematic representation of the female incontinence catheter according to the invention in the female urethra with the valve open,
• FIG. 8th a schematic representation of the male incontinence catheter with attached insertion rod in the male urethra during the filling phase of the balloons,
• FIG. 9 a schematic representation of the distal part of the male incontinence catheter in the male urethra at the moment of replacement of the insertion rod,
• FIG. 10 a schematic representation of the distal part of the male incontinence catheter in the male urethra during insertion of the special, rod-shaped removal device,
• FIG. 11 a schematic representation of the distal part of the male incontinence catheter in the male urethra at the beginning of the extraction by the removal device, and
• FIG. 12 a schematic representation of the distal part of the female incontinence catheter in the female urethra at the beginning of the extraction by the removal device.

In the drawings, like reference numerals are used for components and features that are the same in the various embodiments.

According to FIG. 1 the device according to the invention consists of a tubular or tubular catheter, consisting of a proximal part 1 and a detachable distal part 2, both of silicone, for example, whose length is dimensioned so that it with its distal part 2 in the inserted state within the male Urethra 34 ( Fig. 6 ) and its proximal end 3 into the lumen of the bladder 35 (FIG. Fig. 6 ) protrudes. In the vicinity of the proximal end 3, a first balloon 4 is firmly connected to the outside of the catheter part 1. At a short distance distally thereof, a second (smaller) balloon 5 is fixed on the outside of the catheter part 1. From the distal end of the catheter part 2 extends in the wall and of the part 1 a dashed line channel 6, which opens via an opening provided in the catheter wall 7 into the interior of the proximal balloon 4. In addition to the opening 7, a further, opening into the balloon 4 opening 8 is formed in the wall of the part 1 of which from a connecting channel 9 (shown in dashed lines) also extends in the catheter wall to the central balloon 5 and there opens into an opening 10 which has a significantly smaller cross-section than the openings 7 and 8 of the proximal balloon 4. This results in a delayed filling of the balloon 5 in relation to balloon 4 in the introduction of a fluid (eg water) via channel 6 into the balloon 4.

Near the distal end of the catheter part 1 is a third balloon 11 connected to the wall of the part 1, which is defined by a passage 12 in the catheter wall in its interior via a channel 13 extending proximally in the catheter wall and an opening 14 at the proximal end Catheter end 3 opens into a small semi-balloon 15 fixedly connected to the wall of the part 1 and is the main component of an opening mechanism of the valve opening 16. The valve opening 16 is defined by sealing lips which lie sealingly against one another and which are produced by an incision in the catheter end 3 and, in the closed state, are pressed even more tightly against one another by the internal bladder pressure.

The distal catheter part 2 is attached to the catheter part 1. The plastic tube 17 connects the wall channel 6 with an elastic stub valve 19 in the end face of the part 2. The plastic tube 18 continues from a stub valve 20 in the front of the part 2 outgoing wall channel 13a, which runs in the wall of the part 2 and opens inside the balloon 11 in an opening 21. Two loose threads 22 (one thread not visible), one end anchored in the wall of the de-connectable distal part 2 and the other end anchored in the wall of the proximal part 1, provide additional loose connection between the two catheter parts 1 and 2. Proximal of the distal balloon 11 are one or two relatively large openings 23 in the Wall of the part 1 for draining secretion from the proximal urethra into the lumen 24 of the catheter.

How closer Fig. 9 emerges and in the Fig. 1 and 2 is not shown for clarity, at the distal end of the catheter part 2, across the lumen of time, a thread 52 firmly anchored. The thread 52 serves, as explained in more detail below, the insertion and removal of the catheter according to the invention in and out of the urethra.

According to Fig.2 The device according to the invention, which is intended for women, consists of a tubular or tubular catheter, for example of silicone, the length of which is dimensioned such that it can be inserted with its distal end 28 in the inserted state inside the female urethra 38 (FIG. Figure 7 ) and its proximal end 3 protrudes into the lumen of the bladder 39. The catheter consists of two de-connectable parts, a proximal part 25 and a distal part 26.

With the outside of the proximal part 25, a first balloon 4 is firmly connected. From the distal end 28 of the distal catheter part 26, a channel 6 extends in the wall thereof, which continues in the wall of the proximal part 25 and which opens into the interior of the proximal balloon 4 via an opening 7 provided in its wall.

With the wall of the distal catheter member 26, a second balloon 27 is fixedly connected by an opening provided in the catheter wall 12 in its interior via a channel 13 located in the catheter wall and an opening 14 at the proximal end 3 of the proximal catheter part 25 in a the wall of the catheter part 25 tightly connected small half balloon 15 opens and is the main component of the opening mechanism of a valve opening 16.

The distal catheter part 26 is attached to the proximal catheter part 25. As connectors are again two small-lumen plastic tubes 17 and 18. Das Plastic tube 17 connects the wall channel 6 with an elastic stub valve 19 in the end face of the part 26. The plastic tube 18 extends from a stub valve 20 in the end face of the part 26 outgoing wall channel 13a, which opens through an opening 21 within the balloon 27. Two loose threads 22 (one thread not visible), one end of which is anchored in the wall of the distal catheter part 26 and the other end anchored in the wall of the proximal catheter part 25, provide an additional loose connection between the two catheter parts 26 and 25.

In order to change the position of the device in the female urethra 38 upon actuation of the hydraulic trigger mechanism for opening the valve opening 16 by compression of the through the front wall of the sheath 40 (FIG. Fig. 7 ) to avoid palpable balloons 27, the balloon 27 is provided with two to four strip-shaped circular and extending transversely to the longitudinal axis of the device protrusions or ribs 30. If necessary, the protrusions 30 can be replaced by other structures (not shown) that change the surface of the balloon 27 with the same function.

The FIGS. 3, 4 and 5 show details and the function of the present at the proximal catheter end 3 of the male and female devices according to the invention, in the same way draining into the catheter lumen valve.

In the wall of the proximal end of the catheter 3 is under, the valve 16 closing bias voltage through an opening 31, a spring-elastic rod made of metal or plastic 32 sunk in the longitudinal direction. Its ends are entwined by two threads 33, which fix an approximately diamond-shaped, flat against the catheter end 3 and the hemi-balloon 15 fitting fleece 34 of a tissue-compatible material. The nonwoven fabric 34 has a widened shape in its longitudinal center, in order to prevent slippage of the half balloon 15 in its subsequently described bulge. By inflow of a Fluid (eg, water) under pressure across the channel 13 in the wall of the device and out of the opening 14 in the hemi-balloon 15, a filling and thus bulge of the small half-balloon 15 is effected.

By pressing on the wall of the male urethra 34 ( Fig. 6 ) palpable balloon 11 of the male device Fig.1 or by pressure on the front wall of the sheath 40 (FIG. Fig. 7 ) and the wall of the female urethra 38 palpable balloon 27 of the female device Fig. 2 the pressure of a fluid (eg, water) in the channel 13 of the male or female device increases.

As a result of this pressure increase, the half balloon 15 bulges and by the small half balloon 15 covering, largely undeformable nonwoven 34 is applied to the attached to the elastic rod 32 two threads 33 a train so that the plastic rod 32 like a hunting arch together with the wall of the proximal end 3 of the catheter in the direction of the small hemisphere 15 bends. This simultaneously opens the valve 16 located on the opposite side of the proximal catheter end 3 similar to the visor of a medieval knight's helmet and allows the urine flow from the bladder 35 and 39, respectively. After emptying the bladder 35 or 39 and releasing the pressure on the balloon 11 ( Fig. 1 ) or 27 ( Fig. 2 ), the small half-balloon 15 empties by return flow of the fluid (eg water) via channel 13 in the balloon 11 and 27. Above all, this is done by the elastic restoring force of the elastic rod 32, since the bending stress is released in this and this his original Take shape again. The proximal catheter end 3 thereby returns to its original shape and the valve 16 is closed under pressure caused by the rod 32.

FIG. 6 FIG. 12 shows a schematic representation of the anatomy of the male urethra 34 when the bladder 35 is full of male device inserted into the male urethra 34 Fig. 1 , wherein the protruding into the bladder Valve opening 16 is closed. The balloon 11 serving for the hydraulic opening of the valve opening 16 lies approximately at the height of the scrotal extension 36. The sealing balloons 4 and 5 of the device are shown above and below the area of the sphincter muscle 37 in the filled state.

FIG. 7 FIG. 12 shows a schematic representation of the anatomy of the female urethra 38 when the bladder 39 is full with a female device inserted into the urethra 38 Fig.2 whose proximal part 25 (FIG. Fig.2 ) projects with the sealing balloon 4 and the proximal end 3 in the full bladder 39. The index finger 41 inserted into the outer opening of the sheath 40 compresses the balloon 27 of the device which can be felt by the anterior wall of the sheath 40 and the posterior wall of the urethra 38, the symphysis 42 being part of the bony pelvic ring serving as an abutment. As a result, the hemi-balloon 15 of the proximal catheter end 3 is arched up and the valve 16 is opened, as a result of which the urine flows into the lumen of the device in the direction of the arrow.

FIG. 8th shows a schematic representation of just introduced into the male urethra 34 but not yet defined male device with a special, rigid or partially elastic, sterile plugged filling and insertion rod 43, the proximal end 3 into the bladder 35 with deflated half balloon 15 and thus closed Valve 16 protrudes. The sealing balloon 4 of the proximal part 1 is already filled by fluid (eg water) by means of a syringe 45 placed on a valve 44 of the insertion rod 43, which corresponds to a known catheter valve. The second sealing balloon 5 of the proximal catheter part 1 is not deployed yet.

In this case, a possible simplistic design variant of the male device is indicated, which consists in that balloon 4 and balloon 5, omitting the channel 9 by a single existing in the wall of the device channel. 6 ( Fig. 1 ) are rectilinearly interconnected, wherein the single opening 7 in the catheter wall within the balloon 4 has a much larger cross-section than a channel 6 connected to the opening 10 a of the balloon 5, so that after filling the balloon 4 remains a short period of time to the Pull the device by pulling it back to the in-position position with a slight pull on the insertion rod 43. The balloon 4 is above the, even with incontinents still existing, natural narrowness of the urethra 34 in the region of the sphincter 37 to lie. Only then fills, as in the construction in Fig. 1 represented by the throttling action of the opening 10a of the balloon 5 with fluid (eg water). In the Fig. 1 shown additional wall opening 8 within the balloon 4 and the corresponding channel 9 are not present.

The balloon 11 is filled with a few milliliters of fluid (e.g., water) through the guide rod 43 after reaching the proper position of the device as described in the male urethra 34 by means of a syringe 46 through a valve 47 of the same type. In order to avoid a simultaneous maximum filling of the hemi-balloon 15 at the proximal end 3 of the device, the openings 21 and 12 in the wall of the proximal catheter part 1 within the balloon 11 may have a different cross-section such that the opening 12 has a slightly smaller cross-section than the opening 21 has.

FIG. 9 shows a schematic representation of a partial view of the distal part of the male device after Fig. 1 in the male urethra 34 at the moment of detachment of the insertion rod 43 from the distal part 2 of the device after the balloons 4,5 and 11 (FIG. Fig. 8 and Fig. 1 ) after injection of fluid (eg water) via the valves 44 and 47 are already filled by cannula-like, round-tip projections 48 and 49 of the guide rod 43 and by the elastic stub valves 19 and 20 in the distal part 2 of the device. (Balloon 4 and 5 not shown)

In the insertion rod 43 a longitudinally displaceable, rod-shaped core 50 is guided, which is so far inserted with its front end portion 50 b in the lumen of the catheter that it overlaps the separation point between the parts 1 and 2 (in Figure 9 shown in dashed lines). This is intended to stiffen the separation point during insertion of the catheter and the separation point bridging tube 17,18 be protected from bending. In the exemplary embodiment, the front end section 50b is set down in a semicircular cross-section in order to be able to pass through the thread 52 which transverses the lumen of the distal part 2 of the device and is firmly anchored to the wall of the distal part 2 of the device. At the rear end of the end portion 50b, the shoulder formed by this has a notch 51 which receives the thread 52. Dislocation of the device in the extraction of the guide rod 43 due to a, at the beginning of the positioning of the device in the male urethra 34 necessary, adhesion of the needles 48 and 49 of the guide rod 43 in the needle valves 19 and 20 is by light pressure on the outer end 50 a of the core rod 50 avoided.

The positioning of the female device after Fig. 2 in the female urethra 38, Fig. 7 takes place in the same way (not illustrated) with the help of a structurally identical, possibly slightly shorter insertion rod 43 after Fig. 8 ,

10 and 11 show a schematic representation of a partial view of the male device after Fig. 1 during the process of removal from the male urethra 34. A special rigid or partially elastic sterile extraction rod 53 is provided with its end provided with a rounded, harpoon-like appendix blind first into the male urethra 34 and then into the open lumen 24 of the distal part 2 of the device. During the subsequent retraction of the extraction rod 53 takes one of two or more rounded barbs 55 of the extension 54 to the transverse to the lumen of the distal part 2 and firmly anchored in the wall thread 52. By further pulling on the extraction rod 53 (by an arrow is in Fig. 11 the pulling direction is shown), the distal part 2 is released from the proximal part 1 of the device. The two plastic tubes 17 and 18 are extracted from the lumens of the wall channels 6 and 13, whereby the balloons 4, 5 and 11 in the lumen of the openings of the channels 6 and 13 thereby released in the wall of the proximal part 1 of the device of the urethra 34 (shown by arrows). The parts 1 and 2 remain connected by the two exciting threads 22, which are firmly anchored in the walls of the parts 1 and 2. By further pulling on the extraction rod 53, the entire device can now be easily extracted from the male urethra 34.

Fig. 12 shows a schematic representation of a partial view of the female device after Fig. 2 during the process of extraction from the female urethra 38. After insertion of a with 10 and 11 basically identical, possibly shorter extraction rod 53 into the female urethra 38 and its tip 54 into the distal open lumen 24 of the distal part 26 of the device, the rounded barbs 55 of the harpoon-like extension 54 of the extraction rod 53 caught in the lumen 24 of the distal part By pulling back the extraction rod 53, the distal part 26 is separated from the proximal part 25. The two fluid-filled balloons 27 and 4 deflate via the wall channel 13 partially forming, with part 26 of the device firmly connected plastic tube 18 and thereby simultaneously open lumen of the wall channel 6 of the proximal portion 25 of the device (shown by arrows) in the female urethra 38. The female device is removed from the female urethra 38 by further pulling on the extraction rod 53 (arrow indicates the pulling direction).

Basically, the process of extraction of the male device after Fig. 1 from the male urethra 34, 10 and 11 and the female device Fig.2 from the female urethra 38, Fig. 12 also done under visual sight with a cystocop with the help of a known foreign body forceps.

The emptying of the balloons 4, 5 and 11 or 4 and 27 required for the extraction can also be achieved via a modified construction, which is not shown in the drawings. In this construction it is provided that the associated channels 6 and 13 are accessible via a respective directed to the lumen of the catheter, expediently attached to the distal end of the catheter "window", which can be selectively destroyed for the purpose of extraction. This window may be a closed by a membrane orifice at the time of destruction by means of a probe or foreign body forceps.

In the context of the invention may be departed from the embodiments described above. Thus, the invention is not limited to the realized by an incision embodiment of the valve 16 at the catheter end 3. Rather, all valves are conceivable that release an inlet opening by a hydraulic actuation at the catheter end 3. Furthermore, it can be considered that the serving as a transmission element fleece 34, which opens the valve 16 by bending deformation of the elastic rod 32, to be protected by a membrane or the like from adverse effects of the urine. Such a membrane can largely enclose the catheter end 3 in the area of the fleece 34, but without exerting a mechanical reaction on it. Instead of the web 34, any surgical material capable of transmitting a tensile force to the resilient rod 32 without appreciable elastic strain can be used.

Furthermore, it is also not absolutely necessary to fill the actuating balloon 11 or 27, by which the hemisphere 15 of the actuating mechanism is brought to bulge, with fluid only after insertion of the catheter. Rather, the fluid may be contained in advance in the closed system formed by the actuating balloon 11 or 27, the channel 13 and the half-balloon 15.

Claims (24)

1. Device for the treatment of human urinary incontinence comprising
   a catheter (1, 2) which can be inserted into the urethra and carries a balloon arrangement (4, 5 or 4, 27) which can be filled with fluid to close off the urinary bladder and to hold the catheter in the lumen of the urethra, which fluid can be admitted to and discharged from this balloon arrangement via at least one channel (6, 9, 13a) extending along the catheter wall which is closed off at the distal end of the catheter, and
   a self-closing valve (16) mounted at a proximal end section (3) of the catheter, which end section being situated in the lumen of the urethra when the catheter is in its inserted condition,
   whereby the length of of the catheter (1, 2) is dimensioned such that its distal end in the inserted condition lies within the urethra and the valve (16) can be actuated by an actuating mechanism (15, 32, 34) outside thr urethra,
   characterized in that the actuating mechanism (15, 32, 34) is operated hydraulically for opening the valve (16) and that the actuating mechanism (15, 32, 34) can be hydraulically pressurized by mechanical pressure exerted on an actuating balloon (11, 27) located at the distal end section of the catheter (1, 2) and which is filled with fluid and connected to the actuating mechanism via a connecting channel (13).
2. Device in accordance with claim 1, characterized in that the valve (16) is an elastically resilient flap valve which can be lifted from its valve seat by an actuating element (15) of the actuating mechanism.
3. Device in accordance with claim 2, characterized in that the flap valve (16) is a lateral slit opening (16) in the proximal end section (3), the edges of which form sealing lips.
4. Device in accordance with claim 2 or 3, characterized in that the actuating mechanism comprises a substantial non-elastic traction element (34) which is deflectable by the actuating element (15).
5. Device in accordance with claim 4, characterized in that the actuating element is a hydraulically expandable membrane (15), one side of which can be hydraulically pressurized via the connecting channel (13) and through the expansion of which the tensioned traction element (34) is deflectable.
6. Device in accordance with one of the claims 2 to 5, characterized in that the flap valve (16) can be closed off by a resilient elastic section (32) of the proximal end section (3).
7. Device in accordance with claim 6, characterized in that the resilient elastic section is formed by a flexible elastic spring rod (32) located in the catheter wall.
8. Device in accordance with claim 4 and one the claims 5 to 7, characterized in that the traction element (34) is a traction band tightly covering the expandable membrane, the ends of which are permanently connected to the areas of the proximal end section (3) associated to the sealing lips of the valve (16).
9. Device in accordance with one of the claims 1 to 8, characterized in that the actuating mechanism (15, 32, 34) is surrounded by a protective membrane.
10. Device in accordance with one of the claims 1 to 9, characterized in that the actuating balloon (11, 27) can be filled with fluid via a closed channel (13a) at the distal and of the catheter.
11. Device in accordance with one of the claims 1 to 10, characterized in that the balloon arrangement for closing off the urinal bladder and holding the catheter in the bladder lumen in the male device is formed by a first balloon (4) at the proximal end (3) and a second balloon (5) located distally from the first balloon (4), which with the catheter in inserted condition lies outside the bladder sphincter muscle.
12. Device in accordance with one of the claims 1 to 10, characterized in that the balloon arrangement for closing off the urinal bladder and holding the catheter in the bladder lumen in the female device is forrned by a first balloon (4) at the proximal end (3) and the actuating balloon (27).
13. Device in accordance with claim 12, characterized in that the actuating balloon (27) has protrusions on its outer surface for fixing its position.
14. Device in accordance with one of the claims 1 to 13, characterized in that the catheter consists of a proximal part (1) and a distal part (2) which are linked separably by a plugged connection (17, 18) and are connected together by a tensile connection (22) after separation of the plugged connection.
15. Device in accordance with claim 14, characterized in that the plugged connection comprises small pipes (17, 18) extending from the proximal face end of the distal part (2) and being insertable into openings of the channels (6, 13, 13a) at the distal end of the proximal part (1) and forming a continuation of these channels to the distal end of the catheter (1, 2).
16. Device in accordance with claim 14 or 15, characterized in that the tensile connection between the proximal part (1) and the distal part (2) is formed by a thread (22) whose length permits the separation of the plugged connection (17, 18).
17. Device in accordance with one of the claims 14 to 16, characterized in that a hooking element (52) is attached to the distal end of the distal part (2) in which an extraction instrument (53, 54, 55) can engage during extraction of the device.
18. Device in accordance with claim 17, characterized in that the hooking element is formed by a threard (52) extending cross-wise over the distal catheter opening which, at the same time, forms a contact element for an insertion device during insertion of the catheter.
19. Device in accordance with one of the claims 14 to 18, characterized in that it includes a rod-like core (50) for the enabling of its insertion into the male urethra which core is shiftably located in the said shaft (43) and the front of which (50b) can be pushed out of the shaft (43) to contact the distal end of the catheter.
20. Device in accordance with claim 19, characterized in that the front end section (50b) of the core (50) can be inserted into the lumen of the catheter up to a stop (51) and in inserted condition reinforcingly bridges a joint in the catheter consisting of a proximal part and a distal part (1 or 2).
21. Device in accordance with claim 20, characterized in that the cross-section of the front end section (50b) is smaller in respect to the core (50) and that the stop is a shoulder (51).
22. Device in accordance with one of the claims 19 to 21, characterized in that the rear end (50a) of the rod-like core (50) protrudes from the shaft (43) as an actuating end.
23. Device in accordance with one of the claims 19 to 22, characterized in that the insertion device is, at the same time, designed as a filling device to allow the balloons to be filied with fluid in that the front end of the shaft (43) is designed as a plug connection with canulae (48, 49) which can be pushed into puncture valves (19,20) in the face end of catheter part (2) and which are connected to connectors (44, 47) being formed at the shaft (43) via leading channels formed within the shaft (43).
24. Device in accordance with one of the claims 1 to 18, characterized in that a hooking element (52) is provided in the lumen of the catheter (1, 2) and that an extraction rod (53) which enables an extraction of the device is insertable into the urethra, whereby an extension element (54) having at least one barb is formed at the front end of said extraction rod and being insertable into the lumen of the catheter (1, 2) in which the said extension element is hookable with the barb (55) into the hooking element provided there.

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